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Acne cases pile up after Valisure study, could be put in an MDL

LEGAL NEWSLINE

Saturday, November 23, 2024

Acne cases pile up after Valisure study, could be put in an MDL

Federal Court
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Light | https://www.valisure.com/team/david-light

CHICAGO (Legal Newsline) - More than 30 lawsuits have now been filed after a controversial drug-testing lab with a mystery government contract claimed acne medicine turns into benzene.

Valisure's drug-testing methods in another case were deemed unreliable, but that didn't stop it from earlier this year filing a citizen petition that said its testing showed benzoyl peroxide in acne medicines turns into benzene.

Class action lawyers unsurprisingly picked up on the study to file lawsuits. One woman sued five companies in one day.

With complaints starting to pile, the body that creates multidistrict litigation proceeding is now weighing a request to consolidate them into a single MDL. The panel did not have the issue on its agenda for a May 30 meeting in Utah, and it next meets July 25 in Maine.

Companies like L'Oreal, Target and Clinique face litigation that began with Valisure's report earlier this year. Valisure notably kickstarted an MDL over Zantac, heating an artificial stomach to more than 250 degrees Fahrenheit to turn its ingredients into NDMA.

A federal judge and the FDA found fault with Valisure's testing, which also included a lethal dose of salt into the artificial stomach. It is still calling itself a whistleblower as it seeks to represent the interests of nearly 30 states and the federal government - all of whom refused to join that lawsuit.

David Light, Valisure's CEO, ran afoul of the law while at Yale University when police discovered an illegal arsenal of weapons and explosives that led to a one-year prison sentence. 

The lab has said it scored a drug-testing contract with the Department of Defense, though Legal Newsline's efforts to track it down have so-far been rejected. Several FOIA requests are pending. 

For its acne medicine study, Valisure says it heated various benzoyl peroxide acne medicines to 170 degrees Fahrenheit and found “concerningly high levels of benzene in only 18 days.” Valisure said the temperature was a reasonable estimation of what might occur in a shipping container or a hot car.

Defendants in other cases have fired back at the lab, accusing Valisure of coordinating efforts with lawyers – including the brother-in-law of Light – by sharing reports with them before filing citizen petitions the with the FDA. The lawsuits filed so far over acne medicine contain large passages, including diagrams, copied directly from Valisure’s FDA filing.

Other court documents suggest Valisure has found a profitable niche providing consulting services to companies that might otherwise find themselves in the crosshairs of a lawsuit based on the lab’s testing results. Unilever cited a September 2022 letter from Valisure’s lawyer, Marty Sipple, offering to test Unilever’s aerosol products for benzene for an up-front payment of $1.25 million and $250,000 a month, promising to keep results confidential. 

In that court filing, Unilever suggested Valisure might have been offering to keep test results for its products out of a petition it later filed with the FDA.

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